700180
Aire-Master of America Inc — FEI 3002764676
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nixa, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2022 | 21 CFR 211.188(b)(10) | Documentation of Sampling Performed |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |